Synthetic PET From CT Improves Precision Diagnosis and Treatment of Lung Cancer: a Prospective, Observational, Multicenter Study

NCT07243873 | Recruiting

• 1 other identifier: PETgeneration
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 5

Brief Summary

This study aims to synthesise PET data that preserves biological relevance and adds clinical value to the diagnosis and prognosis of lung cancer by establishing anatomical-to-metabolic mapping based on paired diagnostic CT and FDG-PET scans, thereby prospectively validating the clinical utility of the model.

Conditions

Lung Cancer; PET-CT

Outcome Measures

Primary Outcomes (4)

• Structural similarity

  This is a core outcome measure evaluating the degree of resemblance between the structural characteristics of synthetic PET images and reference PET images. It reflects whether the synthetic PET retains the key structural information of the original image, which is a fundamental indicator for confirming the structural relevance of synthetic PET.

  2025.12.1-2026.12.1

• Peak Signal-to-Noise Ratio (PSNR)

  A commonly used objective evaluation index in image quality assessment, calculated based on the mean square error between the synthetic PET image and the reference image. It quantifies the ratio of the maximum possible signal value in the image to the noise power that affects image quality. Higher PSNR values indicate that the synthetic PET image has less noise interference and better consistency with the reference image in terms of signal characteristics, thereby reflecting better retention of structural information.

  2025.12.1-2026.12.1

• Structural Similarity Index (SSIM)

  An index designed to simulate human visual perception to evaluate image structural similarity, which comprehensively considers three aspects: brightness, contrast, and structural consistency between the synthetic PET image and the reference image. The value range is between 0 and 1; a value closer to 1 means that the synthetic PET image has a higher degree of structural consistency with the reference image, indicating that the structural relevance is well retained.

  2025.12.1-2026.12.1

• Metabolic Parameter Consistency

  A key outcome measure for verifying the biological relevance of synthetic PET, which evaluates whether the metabolic characteristic parameters derived from synthetic PET are consistent with those from reference PET. Metabolic parameters are directly related to the biological functions of tissues/organs, so their consistency is crucial to ensuring that synthetic PET can be used for accurate biological activity assessment.

  2025.12.1-2026.12.1

Secondary Outcomes (1)

• predictive performance

  2025.12.1-2026.12.1

Interventions

PET-CT DIAGNOSTIC_TEST

A PET-CT scan is performed prior to initiating systemic treatment for the tumour.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-small cell lung cancer scheduled to undergo PET-CT and pathological examinations

You may qualify if:

• Patients with non-small cell lung cancer scheduled to undergo PET-CT and pathological examinations;
• Voluntarily participate and sign an informed consent form;

You may not qualify if:

• History of other malignant tumours;
• Image artefacts;
• Without pathological diagnostic information;
• Without paired CT and FDG-PET scan images.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (5)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Jiangxi, Nanchang, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Central Study Contacts

Xinchen Shen

CONTACT

17366690957; shenxinchen9@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)